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Mylan IRE Healthcare Limited

Newenham Court, Northern Cross, Malahide Road, Dublin 17, Ireland
Medical Information Direct Line: +44 (0)1748828888
Medical Information e-mail: medinfo.shl@mylan.com
Summary of Product Characteristics last updated on medicines.ie: 13/07/2017
SPC Teveten 600mg Film-coated Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13/07/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Jul-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 6.5, deletion of bottles as immediate packaging container
Updated on 05/07/2017 and displayed until 13/07/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Jun-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



7.  MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

BGP Products Ireland Limited

4051 Kingswood Drive,

Citywest Business Campus,

Dublin 24

8. MARKETING AUTHORISATION NUMBER

 

PA 2010/17/2 2007/14/2

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 14/04/2015 and displayed until 05/07/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   27-Mar-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 7:
MA Holder changed from Abbott Healthcare Products Limited to BGP Products Ltd

Section 8:
PA Number changed from PA 108/23/4 to PA 2007/14/2 
Updated on 27/01/2015 and displayed until 14/04/2015
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   22-Jan-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.3 Contraindications
Addition of bullet point - The concomitant use of Teveten with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GRF < 60ml/min/1.73 m2) (see section 4.5 and 5.1)

Section 4.4 Special warnings and precautions for use
Addition of a separate paragraph in relation to Doal blockade of the renin-angiotensin-aldosterone system (RAAS)
Updating "Eprosartan" with "angiotensin II receptor blockers"

Section 4.5 Interaction with other medicinal products and other forms of interaction
Deletion of the following paragraphs:
"No effect on the pharmacokinetics of digoxin and the pharmacodynamics of warfarin or glyburide (glibenclamide) has been shown with eprosartan.  Similarly no effect on eprosartan pharmacokinetics has been shown with ranitidine, ketoconazole or fluconazole"
"Eprosartan can be used concomitantly with thiazide diuretics (e.g. hydrochlorothiazide) and calcium channel blockers (e.g. sustained-release nifedipine) without evidence of clinically significant adverse interactions"

Addition of the following paragraph:
"Clinical trial data has shown that dual-blockade of the renin-angiotensis-alderstone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1)"    
 
Section 4.6 Pregnancy and lactation
Updating "eprosartan" with "angiotensin II receptor blockers"

Section 4.8 Undesirable Effects
Updating with a paragraph in relation to Reporting of Suspected Adverse Reactions

Section 5.1 Pharmacodynamic Pproperties
Addition of a paragraph in relation to two large randomised, controlled trials - ONTARGET and ALTITUDE

Section 5.3 Preclinical safety data
Removal of the following line in relation to Reproductive and Developmental toxicity in pregnant rabbits
"This is most likely due to effects on the renin-angiotensin aldosterone system"
Updated on 14/11/2014 and displayed until 27/01/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   24-Aug-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 7 changed:
 
from:

Abbott Healthcare Products Limited.,
Mansbridge Road
West End
Southampton
SO18 3JD
UK



to:

Abbott Healthcare Products Limited.,

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

SL6 4XE,

UK.

Updated on 05/12/2012 and displayed until 14/11/2014
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Oct-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


The following sentence has been added to section 4.9 Overdose:

There have been individual reports from postmarketing experience where doses up to 12,000 mg had been ingested. Most patients reported no symptoms. In one subject circulatory collapse occurred after ingestion of 12,000 mg eprosartan. The subject recovered completely.
Updated on 30/11/2011 and displayed until 05/12/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   28-Nov-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Update of sections 4.4, 4.5 & 4.8 of the SPC in line with the EU Core Safety Profile for Eprosartan
Updated on 17/06/2010 and displayed until 30/11/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   10-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Warnngs and precautions concerning use in pregnancy and lactation have been updated and the name of the MAH has changed to reflect new ownership.

In particular, in section 4.3 the product is no longer contra-indicated in lactation although in section 4.6 it is recommended that patients are switched to products with a better established safety profile especially when nursing newborn or preterm infants.

The information on the use during pregnancy (sections 4.4 and 4.6) has been revised by including more detail of the possible risk to the foetus to enable prescribers to make a better informed treatment decision.

In section 7, the name of the MAH has been changed to Abbott Healthcare Products Ltd.

 

Updated on 23/12/2008 and displayed until 17/06/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 5.1 Inclusion of MOSES trial data into the SPC
Updated on 21/01/2005 and displayed until 23/12/2008
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Updated on 16/11/2004 and displayed until 21/01/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Updated on 27/06/2003 and displayed until 16/11/2004
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Eprosartan mesilate